On April 25-26, 2013, the U.S. Food and Drug Administration (FDA) held a workshop on drug development related to ME/CFS. This was the first of 20 disease-specific meetings held by the FDA as part of a mandated “Patient-Focused Drug Development Initiative” where the FDA committed to soliciting patient perspectives to inform benefit-risk assessment for drug development.

The Association wanted to make sure as many patients as possible had an opportunity to provide their perspective and lend their voice to the meeting. Using questions posed by the FDA and other we believed were important to convey the experience of living with ME/CFS, we conducted an online survey asking questions about the impact of ME/CFS on lives, symptoms experienced and treatments used.

More than 1,400 people responded to this survey. We reported the results at the FDA meeting to represent the patient voice during the proceedings. The survey results indicate that the majority of people (86%) have been diagnosed with ME/CFS by a healthcare professional. Only 17.5% of people said ME/CFS was their only condition; most people deal with multiple conditions and diagnoses that require management. The average age that people indicated their ME/CFS began was 32 years of age. On average, patients have been sick for 18 years.

“I was moved to tears while reviewing and analyzing the responses about the impact of ME/CFS on individuals, their family and friends,” said Suzanne Vernon, PhD, Association scientific director. “There was a great deal of expression of loss and sadness from ‘this miserable disease.’ Many described how ME/CFS changed their lives from active, productive citizens to one of isolation and loneliness.”Throughout the responses people expressed uncertainty and fear about their life because of the lack of effective treatments and the increased risk of disease and death. Many patients can no longer work, many have lost friends and relationships, and many mourned the loss of being active.CFS Word Cloud

When asked what are the most significant symptoms experienced because of ME/CFS, extreme exhaustion, muscle pain, cognitive impairment, and cold intolerance, were consistently named.

The graph below shows the treatments used by ME/CFS patients. More than 70% of ME/CFS patients take nutritional supplements and on-drug therapies such as diet modifications, rest, taking naps and activity modification to treat their symptoms. FDA-approved medicines and over-the-counter products are used by more than 50% of ME/CFS patients. Slightly more than 40% of patients use a variety of other treatments such as massage therapy, yoga, acupuncture and meditation to treat their ME/CFS. When asked about the efficacy of these treatments, the range of responses varied from no effect to helping relieve one or a few ME/CFS symptoms.

We learned through this survey and at the FDA Drug Development meeting for CFS and ME that individuals experience and describe their ME/CFS in different ways. Understanding patients’ perspectives is critically important for drug development and getting safe and effective treatments to patients who need them. These perspectives give us the information on the symptoms that are most important to treat. Documenting and analyzing patient perspectives also gives us the most important clues to possible causes of ME/CFS. This makes the more than 750,000 words provided by the more than 1,400 survey respondents absolutely invaluable. As we dive deeper into these responses it will help inform us of the most important and appropriate things to treat and the most important effect to measure in clinical trials.

It is quite possible that this survey will turn out to be one of the most important patient-centered studies done to date. We will keep you updated as we dive deeper into your data.